Trade-related policies and access to medicines

1
Trade-related policies and access to medicines

• ICTSD Consultation on trade policy coherence and
  access to medicines
• Geneva
• November 7th 2006,

2
Road map

• The context
• ICTSDs Project on trade-related policy coherence
  and access to medicines
• Objectives of the project
• General methodology
• Relevant policies and parameters
• Outputs and outcomes

3
The context

• MDGs To Combat HIV/AIDS, Malaria and other
  diseases
• WTO the TRIPS and Public Health Declaration
• The Amendment process to Art. 31 f) of the TRIPS
  Agreement
• Proposals in the WTO Negotiating Group on Market
  Access (industrial goods) and various requests in
  the special sessions of the Services Council
• The CIPIH Report

4
The context

• WHO Assemblies Resolutions 2006
• to consider the interplay between international
  trade and health to take advantage of the
  potential opportunities and address the potential
  challenges that trade and trade agreements may
  have for health
• to apply or establish, where necessary,
  coordination mechanisms involving ministries of
  finance, health and trade, and other relevant
  institutions, to address public health related
  aspects of international trade
• and () to continue collaborating with the
  competent international organizations in order to
  support policy coherence between trade and health
  sectors

5
The context

• What is trade related policy coherence?
• Trade policy coherence involves the systemic
  promotion of mutually reinforcing policy actions
  across government agencies creating synergies
  toward achieving agreed objectives (OECD)
• What is access to medicines?
• Drugs and medicines that satisfy the health
  needs of the majority of a countrys population
  and ought to be available at all times, in
  adequate dosage, and at prices that all
  individuals can afford (WHO)
• The need for a two fold perspective in trade
  policy coherence
• the transformation and adequate implementation of
  international trade obligations into national law
  and policy bearing in mind national development
  goals (i.e. health welfare)
• the adequate design of domestic policies given
  the policy space available in WTO Agreements and
  FTAs.

6
ICTSDs project on trade related policy coherence
and access to medicines

• Objective of the Project
• enhancing trade related policy coherence in
  order to facilitate the
• creation of an enabling framework for sustainable
  access to essential
• medicines in developing countries
• More specifically the project seeks to
• Provide a better understanding of the interface
  between different trade-related policies
  impacting access to essential medicines in
  selected developing countries
• Identify mechanisms and policy options for
  improving trade-related policy coherence in
  promoting access to medicines in selected
  developing countries

7

Trade-related policy coherence and access to
medicines

• General methodology
• The specific objectives of the project will be
  achieved through applied policy, legal and
  economic research and informal multi-stakeholder
  dialogues at the national level
• The project will focus on 3-4 developing
  countries in Latin America, Asia and Africa
• Pre-selected countries could include Ghana,
  Jordan, Peru and South Africa
• Engagement by national governments and relevant
  stakeholders is needed for the success of the
  project

8

Trade-related policy coherence and access to
medicines

• Some trade related policies to be analyzed
• Market access in goods
• Applied tariffs on bulk active ingredients,
  finished pharmaceutical products and medical
  devices
• Existence of exemptions, waivers or reductions in
  special cases
• Non tariff barriers
• Domestic taxes and price regulations
• VAT, other domestic taxes
• Price controls schemes
• FDI regimes
• Enabling environment
• Investment definition and standards of protection
• Use of performance requirements
• Competition law and policy

9

Trade related policy coherence and access to
medicines

• Some trade related policies to be analyzed
• Market access and regulation in health related
  services
• Medical and dental services
• Midwife and nursing services
• Hospital services
• Other human health services
• Health insurance
• Data transfer
• Intellectual property regulation
• Parallel imports
• Compulsory licenses
• Test data exclusivity
• The linkage between marketing approval and patent
  protection
• Second uses
• Exceptions and limitations
• Government procurement regulation

10

Trade-related policy coherence and access to
medicines

• Other parameters to be taken into the
  consideration within the general framework but
  not subject to policy analysis include
• Geographical and environmental related factors
• Political and macroeconomic stability
• The rule of law
• Population and cultural / anthropological
  factors
• Purchasing capacity
• Overall disease burden
• Availability of health infrastructure
• Availability of human resources in the health
  sector
• Supply capacity in the drug sector
• Level of (health related) technological
  development
• Existence of health service delivery systems

11
Trade-related policy coherence and access to
medicines

• Outputs
• Prepare a methodological note and expert
  consultations
• Identify trade-related policies that have an
  impact on access to medicines
• Explore ways to measure impact in an empirical
  manner
• Undertake national case studies
• Map national trade-related policies at the
  national level
• Identify areas where synergies or lack of
  coherence
• Evaluate impact to the extent possible
• Organize national dialogues
• Expose national stakeholders to the findings of
  the studies
• Generate policy recommendations based on the
  dialogue
• Prepare synthesis report
• Comparative analysis of national experiences
• Compilation of findings and policy
  recommendations arising from the dialogues

12
ICTSDs project on trade-related policy coherence
and access to medicines

• Outcomes
• Clearer understanding of national trade-related
  policies and their impact on access to medicines
  by relevant stakeholders
• Identify of mechanisms and policy options for
  improving trade-related policy coherence in
  promoting access to medicines
• Ultimately, if stakeholders decide to take action
  based on the recommendations made, there could be
  domestic policy reform and adjustment for the
  creation of an enabling trade-related framework
  for attaining sustainable access to essential
  medicines
• Other international organizations that could also
  assist in the process of reform and adjustment
  process include the WHO, UNCTAD, WTO, WB and
  various civil society organizations